MedTrace Logo

GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

NCT05316935 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-11

No results posted yet for this study

Summary

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

Conditions

  • Endometrial Neoplasms
  • Atypical Endometrial Hyperplasia
  • Progesterone Resistance

Interventions

DRUG

GnRHa

Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.

DRUG

Letrozole 2.5mg

2.5mg po qd and no more than 24 weeks

DRUG

Diane-35

Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.

DRUG

MET

500mg po tid

Sponsors & Collaborators

  • Xiaojun Chen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2026-03-30
Completion
2027-03-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05316935 on ClinicalTrials.gov